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Apr27
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Rib-X Pharmaceuticals, Inc. and the Laboratory of Molecular Biology of the Medical Research Council (MRC) have entered into a research collaboration in the area of ribosome and antibiotic structure and function. Under the terms of agreement, Rib-X and the MRC will jointly explore the high resolution crystal structure of the full 70S ribosome recently discovered by the MRC's world-renowned ribosome scientist, Venki Ramakrishnan, Ph.D.  The 70S ribosome is a macromolecular machine composed of protein and RNA whose function is to convert genetic information into proteins essential for life, composed of two major components: a large (50S) and a small (30S) subunit.
According to Dr. Susan Froshauer, President and Chief Executive Officer of Rib-X: "Rib-X is very pleased to be able to collaborate with Dr. Ramakrishnan and the MRC in this important research area. We are excited about the prospect of building on our knowledge to further our insights into how antibiotics interact at the atomic level with disease producing bacteria." Find more details from the full report.
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Apr27
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The USFDA has approved the marketing of Eli Lilly and Company (NYSE: LLY)’s treatment for canine separation anxiety in conjunction with behaviour modification training: Reconcile™. Reconcile™ (fluoxetine hydrochloride), the first selective serotonin reuptake inhibitor (SSRI) class of antidepressants approved by...
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Cytos Biotechnology AG (SWX: CYTN) has entered into an exclusive global commercial license agreement with Novartis (NYSE:NVS) for the development, manufacturing and commercialization of CYT002-NicQb – a novel therapeutic vaccine under phase II clinical development for the treatment of nicotine...
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Preclinical pharmacokinetic testing of ANX-514 (docetaxel emulsion) in a well recognized animal model, yielded positive data as recently announced by ADVENTRX Pharmaceuticals, Inc. (Amex: ANX). Results of the study indicated the following: Bioequivalent pharmacokinetics between ANX-514 and the FDA-approved version...
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Apr26
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The pharmaceutical magazine R&D Directions selected Avicena Group, Inc. (OTC: AVGOE)'s lead Huntington's disease drug candidate, HD-02, as one of the "100 Great Investigational Drugs of 2007" in the magazine’s March issue. Huntington’s disease (HD) is a progressive neurodegenerative disease...
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A non-exclusive, worldwide license of cytochrome P450 intellectual property has been granted by Astex Therapeutics to GlaxoSmithKline (NYSE: GSK). Cytochromes P450 (CYP450) are the most significant group of drug-metabolising enzymes in humans. The action of these enzymes is the cause...
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Neuromed Pharmaceuticals Ltd. has been granted the exclusive U.S. rights for the development and commercialization of OROS® Hydromorphone by ALZA Corporation. An extended release formulation of a potent opioid analgesic undergoing Phase 3 clinical development, OROS® Hydromorphone was developed by...
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The USFDA has granted Exelixis, Inc. (Nasdaq: EXEL) the go signal to initiate its clinical trial (following approved review of the protocol) of XL999 in patients with non-small cell lung cancer (NSCLC). Developed by Exelixis, XL999 is a potent inhibitor...
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Apr25
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Pharmos Corporation (Nasdaq: PARS)'s intravenous (i.v.) cannabinor passed phase 2a clinical trial in post-operative pain in over 100 male patients undergoing third molar dental extraction. 12 mg cannabinor – the lowest dose used in the single-center, randomized, double-blinded, placebo-controlled, single...
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Amarin Corporation plc (Nasdaq: AMRN) has conducted two Phase II clinical trials for its product candidate for Huntington’s Disease (HD) – Miraxion. Clinical data of the two Phase III double-blind, placebo-controlled studies showed no statistically significant difference in either study...
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Pharmacyclics, Inc. (Nasdaq: PCYC) has recently filed a New Drug Application (NDA) to the USFDA for its Xcytrin® (motexafin gadolinium) Injection, seeking approval to market the drug for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases....
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Apr23
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The USFDA has embraced podcasting in addition to its traditional print- and Web-based public health advisories (PHAs) in order to broaden and speed up its ongoing communications concerning the safety of marketed medications when unexpected adverse events are reported to...
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Results of Sanofi-aventis (NYSE: SNY)’ PREVAIL (Prevention of VTE after Acute Ischemic Stroke with LMWH Enoxaparin) trial has been published in the April 21st issue of The Lancet. Clinical data from the said trial revealed that once daily administration of...
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What: 6th Annual European Drug Delivery Partnerships 2007 When: Tue 15 May 2007 - Wed 16 May 2007 Where: Berlin Marriott Hotel, Berlin, Germany This conference is a practical and strategic networking and partnering event for pharma, biotech and innovative...
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Apr22
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Dear readers, I hope you’ve enjoyed your weekend. With your nightcap, let me direct you to great posts from my immediate blogosphere: Allergizer: Tropicana® Healthy Heart with Omega-3: Not For the Fish Allergic Cancer Commentary: Long Term Daily Dose of...
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Apr21
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Addex Pharmaceuticals has recently reported the positive results of its Phase IIa proof of concept trial with its lead compound ADX10059 in patients with migraine. ADX10059 is a potent, selective, negative allosteric modulator of metabotropic glutamate receptor 5 (mGluR5 NAM)....
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Baxter Healthcare Corporation’s Phase I study of its pulmonary insulin administered using a small, standard dry powder inhaler demonstrated that the insulin powder can be effectively administered to the deep lung using an off-the-shelf dry powder inhaler designed for upper...
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Apr20
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Access Pharmaceuticals, Inc. (OTC: ACCP) and Somanta Pharmaceuticals, Inc. (OTC: SMPM) has just signed a definitive merger agreement wherein Access will acquire Somanta. The terms of agreement include:Access will issue 1.5 million shares of common stock to Somanta stockholders in...
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Allos Therapeutics, Inc. (Nasdaq: ALTH)’s novel antifolate PDX (pralatrexate) for the treatment of patients with peripheral T-cell lymphoma (PTCL) has been granted Orphan Drug Designation by the European Medicines Agency (EMEA). PDX is a novel, small molecule chemotherapeutic agent that...
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Apr19
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The Medicare Fair Prescription Drug Price Act of 2007 – the legislation that could help lower prescription drug costs for millions of Medicare beneficiaries – have been blocked from coming up for a vote on the Senate yesterday, despite the...
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A wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd. (TYO: 4523) - Eisai Corporation of North America – has recently announced the completion of its acquisition of Morphotek®, Inc. (1293437). Morphotek joins Eisai's growing global discovery and development research network, which...
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Actonel® (risedronate sodium tablets) has recently been approved of a new dose (75 mg tablet) by the USFDA which will give patients the option of taking one Actonel 75 mg tablet on two consecutive days, for a total of two...
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Here’s Part 5 of that You Tube video on pharmaceutical companies spending big bucks on advertising. In here is discussed the big money spending of pharmaceutical companies in convincing doctors to use their products or prescribe their products to their...
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Last week, I got a new 3G cellphone. It has been 24 hours since my connectivity at home has reached decent speed (and reception) enough to publish an entry to this blog. [In all my blogs, Pharmagazette’s MT platform is...
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Apr18
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Watch Bill Clinton discuss why we pay so much on prescription drugs in the following You Tube video: ...
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Sirion Therapeutics, Inc.’s anti-viral therapy –ganciclovir – has been awarded Orphan Drug Designation by the USFDA for the treatment of acute herpetic keratitis. Ganciclovir is currently marketed Laboratoires Thea in Europe under the brand name of Virgan®. According to Christine...
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The USFDA has accepted the submitted New Drug Application (NDA) of GPC Biotech AG (Nasdaq: GPCB) for satraplatin in combination with prednisone for patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed. The USFDA has granted Priority Review...
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In this four-part video on You Tube, find out all about the big bucks of advertising inside the pharmaceutical industries. Also watch: Part 1, Part 2, and Part 3....
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The USFDA has awarded its final approval to Mylan Pharmaceuticals, Inc.(8056336) for its Abbreviated New Drug Application (ANDA) for Glipizide and Metformin Hydrochloride Tablets in 2.5 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg strengths. Glipizide and Metformin Hydrochloride...
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The USFDA has recently approved the new 12.5 mg dose of RISPERDAL® CONSTA® [(risperidone) Long-Acting Injection] for the treatment of schizophrenia within specific patient populations (including those with renal and hepatic impairment). Manufactured by Alkermes, Inc. (Nasdaq: ALKS) RISPERDAL® CONSTA®...
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The USFDA has approved Lupin Pharmaceuticals, Inc.’s application for Suprax® (Cefixime for oral suspension 200mg/5ml). The new formulation is an extension of Lupin's flagship anti-infective brand Suprax® (Cefixime for oral suspension 100mg/5ml), a higher concentration formulation that will enable parents...
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The USFDA has recently approved GlaxoSmithKline (NYSE: GSK)’s antibacterial Altabax™ (a pdf file) for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes - the two most common types of bacteria in this kind...
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Cell Therapeutics, Inc. (CTI) (Nasdaq: CTICD)’s XYOTAX™ is a novel biologically- enhanced version of one of the most used cancer drugs -Taxol®. Recently, XYOTAX® has been assigned a Fast Track Designation by the USFDA for the treatment of PS2 (poor...
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Apr17
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Roche (OTC: RHHBY) and Transgene S.A. (EPA: TNG) have entered into an exclusive worldwide collaboration agreement for the development and commercialization of products from Transgene's therapeutic vaccine program against Human Papilloma Virus-mediated diseases. HPV infection is recognized as the necessary...
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Griseofulvin oral suspension (liquid) [GRIFULVIN V®], microsize 125 mg/5mL is a prescription medicine used to treat ringworm and other fungal infections. Glass bottles of this product have recently been voluntarily recalled by the Ortho Dermatological, Division of Ortho-McNeil Pharmaceutical, Inc....
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Novalar Pharmaceuticals, Inc.’s NV-101 is a local dental anesthetic reversal agent that has shown efficacy in pivotal studies. Novalar has already applied for NV-101’s marketing approval to the USFDA. According to Donna Janson, President and Chief Executive Officer of Novalar:...
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Apr16
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Sorry for the seemingly long weekend. I've been out of town for the Philippine Blogging Summit, met bloggers and networked with them. Then I decided to re-visit my old base and catched up with friends whom I haven't seen since...
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Apr12
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The Chinese Food and Drug Administration (SFDA) has approved Schering-Plough Corporation (NYSE: SGP)’s PEGINTRON™ (peginterferon alfa-2b) for the treatment of patients with chronic hepatitis B (the most prevalent infectious disease in China and one of the country's leading causes of...
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Melior Discovery, Inc. is a leader in the transformation of pharmaceutical drug repositioning with its unique theraTRACE platform of multiplexed in vivo models. Now, it has signed a research agreement with Pfizer (NYSE: PFE) enabling the company to utilize its...
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A purified antibody or hyperimmune that is specific for the hepatitis B virus - HepaGam B™ is Cangene's Hepatitis B Immune Globulin Intravenous (Human) which was approved by the USFDA last year for the treatment of exposure to blood containing...
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Apr11
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Abbott’s new coated Niaspan® (niacin extended-release tablets) has recently been approved by the USFDA. Niaspan® - the leading medication in boosting HDL (good) cholesterol - is the only USFDA-approved, once-daily extended-release prescription niacin formulation for the treatment of lipid disorders...
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Discovered by AVEO Pharmaceuticals Inc. (8917542), AV-299 is a highly potent antagonist of hepatocyte growth factor/scatter factor (HGF/SF) that has been found highly efficient against preclinical models of human cancer. AVEO has entered into a development and commercialization agreement with...
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Headquartered in the Genopole biocluster in Evry, France, Novagali Pharma is an emerging ophthalmic pharmaceutical company specialized in ophthalmology. Its product candidate for Vernal Keratoconjunctivitis (VKC) - Vekacia® - has recently passed pivotal Phase III clinical trial. Vekacia® is a...
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Apr10
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CSL Biotherapies is one of the world’s leading manufacturers of influenza vaccine. The company would like to penetrate the American market and so has recently submitted a Biologics License Application (BLA) to the USFDA, seeking approval of its influenza vaccine...
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The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval of Boston Scientific Corporation (NYSE: BSX)’s TAXUS® Express2™ paclitaxel-eluting coronary stent system. According to Jim Tobin, President and Chief Executive Officer of Boston Scientific: "The approval of...
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Wyeth (NYSE: WYE) has completed the purchase of the final 20 percent stake of Wyeth K.K. (WKK), from Takeda Pharmaceuticals Company Limited (TYO: 4502) – making Wyeth the 100% owner of WKK. Wyeth K.K. is engaged in a full range...
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Apr 9
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Eli Lilly and Company (NYSE: LLY) has completed its acquisition of Hypnion, Inc. - a privately held neuroscience drug discovery company focused on sleep disorder research. The said transaction, valued at a total purchase price of $315 million, brings several...
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Apr 4
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It is already Maundy Thursday here in the Philippines. In observance of Semana Santa (Holy Week) in a Catholic country like ours, Maundy Thursday until Easter Sunday is a National Holiday. Offices and business, commercial establishments are mostly closed and even...
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Abbott (NYSE: ABT) has submitted a supplemental Biologics License Application (sBLA) to the USFDA and a Type II Variation to the EMEA, seeking marketing approval of HUMIRA® (adalimumab) as a treatment for moderate to severe chronic plaque psoriasis. Psoriasis is a non-contagious,...
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Apr 3
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An additional indication for CSL Behring (5950871)’s Rhophylac® Rh0(D) (Immune Globulin Intravenous [Human]) has just been granted marketing approval by the USFDA: treatment of immune thrombocytopenic purpura (ITP). Administered intravenously, Rhophylac is indicated to raise platelet counts in Rh0(D)-positive, non-splenectomized...
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The USFDA has just approved GlaxoSmithKline (NYSE: GSK)’s Twinrix® [Hepatitis A Vaccine (Inactivated) and Hepatitis B (Recombinant) Vaccine] for an accelerated dosing schedule: three doses given within three weeks followed by a booster dose at 12 months (0, 7, 21-30...
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Apr 2
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The USFDA’s Office of Cellular, Tissue and Gene Therapies Advisory Committee has recommended the PROVENGE® (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent (or hormone refractory) prostate cancer. The committee found that there is substantial evidence of efficacy...
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KV Pharmaceutical Company (NYSE: KV.A/KV.B) has entered into an agreement with California-based VIVUS, Inc. (NYSE: VVUS)for the purchase of U.S. marketing rights to EvaMist™. EvaMist™, currently completed Phase III clinical trials, is a novel new estrogen transdermal spray developed to...
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GlaxoSmithKline (NYSE: GSK) has submitted regulatory approval to the European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix™ (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Neisseria meningitides serogroups A and C). The conjugate meningococcal vaccine...
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Zelnorm® (tegaserod maleate) is a product of Novartis (VTX: NOVN) for the treatment for irritable bowel syndrome (IBS) with constipation and chronic constipation. Zelnorm® received FDA approval for the short-term treatment of women with IBS with constipation in the US...
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Apr 1
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454 Life Sciences is a majority-owned subsidiary of Curagen Corporation (Nasdaq: CRGN). Recently, 454 Life Sciences has entered into a definitive agreement with Roche allowing Roche (OTC: RHHBY) to acquire the company. The terms of agreement include the following: 454...
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GlaxoSmithKline (NYSE:GSK) has recently submitted a Biologics License Application (BLA) for CERVARIX® (human papillomavirus vaccine, AS04 adjuvant-adsorbed) to the USFDA. CERVARIX® is GSK’s candidate vaccine for cervical cancer, which when approved will be indicated for the prevention of cervical cancer...
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Baxter International Inc. (NYSE: BAX) has recently announced the successful results of its final Phase I/II clinical trial for its adjuvant-free investigational pandemic H5N1 influenza vaccine. Baxter's candidate H5N1 vaccine is derived from H5N1 strain A/Vietnam/1203/2004. Its antigen composition and...
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The 70S ribosome is a macromolecular machine composed of protein and RNA whose function is to convert genetic information into proteins essential for life, composed of two major components: a large (50S) and a small (30S) subunit.
